Post COVID-19 Condition

NCT05531773 | Recruiting

• 1 other identifier: EuCARE - PostCOVID
• Study Type: observational
• Target: 2,300
• Locations: 6 countries
• Sites: 7

Brief Summary

The EuCARE-POSTCOVID study is an observational multicentre study enrolling COVID-19 patients recovered from the acute phase of disease to investigate the prevalence and possible predictors of post COVID-19 condition. The study will retrospectively analyze data already collected at the post COVID-19 outpatients services of the participating centers; furthermore, a prospective cohort study will be performed.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (5)

• Overall incidence of post COVID-19 condition

  through study completion, an average of 3 years

• Persistence of post COVID-19 condition beyond 2-3 months from the acute COVID-19 disease

  through study completion, an average of 3 years

• Predictors of post COVID-19 condition

  through study completion, an average of 3 years

• Long-term organ damage (lung, heart, Central Nervous System, Peripheral Nervous System) associated with post COVID-19 condition

  through study completion, an average of 3 years

• Virological and immunological phenotype of post COVID-19 condition

  through study completion, an average of 3 years

Study Arms (1)

COVID-19 patients

patients recovered from an acute COVID-19 episode

Other: follow up of COVID-19 Patients

Interventions

follow up of COVID-19 Patients OTHER

In each participating center a post COVID-19 outpatient clinic is already working or will be settled up to care COVID-19 patients after the acute phase. At the post COVID-19 clinic patients will undergo routine blood exams and will be visited by Infectious Diseases physicians after recovery from the acute episode of COVID-19 disease. According to the clinical issues of the patients and the procedures of the study, if necessary, the patients will be visited by other practitioners (Pneumologists, Cardiologists, Neurologists, Physiatrist and Psychologists or others). Patients who have been already visited at the post COVID outpatient clinics from 01/03/2020 and for whom data of the acute phase and the follow up have been collected will be enrolled in the study and retrospectively analyzed.

COVID-19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with acute COVID-19 disease from 01/03/2020 to 01/02/2025 at the participating centers will be enrolled in the study; two groups of patients recovered from acute COVID-19 will be enrolled: * Group 1 (hospitalized patients): patients hospitalized for COVID-19 disease; * Group 2 (outpatients): patients diagnosed with mild COVID-19 disease and thus not hospitalized (these patients will be referred to the Clinic of Infectious Diseases by the general practitioner or have received monoclonal antibodies for COVID-19 or antiviral treatments for COVID-19 at the Clinic of Infectious Diseases or have been visited at the Emergency Department of the hospital).

You may qualify if:

• Adult patients, \>18 years old;
• Confirmed diagnosis of COVID-19 disease (positive SARS CoV-2 RNA on naso- pharyngeal swab or upper respiratory sample);
• Mild COVID-19 disease without hospital admission or moderate/severe disease requiring hospital admission for COVID-19 or hospitalization for other medical issues with a positive SARS CoV-2 RNA sample;
• Informed consent for the study.

You may not qualify if:

• death during hospitalization:
• patient's decline to participate in the study.

Sponsors & Collaborators

• Euresist Network GEIE: lead
• ASST Santi Paolo e Carlo: collaborator
• Vilnius University Hospital Santaros Klinikos: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator
• University of Rome Tor Vergata: collaborator
• Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus": collaborator
• St Mary's Hospital, London: collaborator
• Centro Hospitalar Lisboa Ocidental: collaborator

Study Sites (7)

University Hospital Heinrich Heine

Düsseldorf, Germany

RECRUITING

Policlinico "Tor Vergata", Università degli Studi di Roma TOR VERGATA

Rome, Lazio, Italy

RECRUITING

ASST Santi Paolo e Carlo

Milan, Lombardy, Italy

RECRUITING

Vilnius University Hospital, Santaros Klinikos

Vilnius, Lithuania

RECRUITING

Regional Hospital Dr. Juan Graham Casasús

Villahermosa, Tabasco, Mexico

RECRUITING

Centro Hospitalar de Lisboa Ocidental

Lisbon, Portugal

RECRUITING

St. Mary Hospital, Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

Related Publications (1)

• Varisco B, Bai F, De Benedittis S, Tavelli A, Cozzi-Lepri A, Sala M, Miraglia FG, Santoro MM, Ceccherini-Silberstein F, Shimoni Y, Ravid S, Kozlovski T, Konig F, Pfeifer N, Shamsara E, Parczewski M, Monforte AD, Incardona F, Mommo C, Marchetti G. EuCARE-POSTCOVID Study: a multicentre cohort study on long-term post-COVID-19 manifestations. BMC Infect Dis. 2023 Oct 13;23(1):684. doi: 10.1186/s12879-023-08595-0.

  PMID: 37833640 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples and a nasopharyngeal swab at COVID-19 diagnosis

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• ANTONELLA D'ARMINIO MONFORTE, PROF

  ASST SANTI GIOVANNI E CARLO

  STUDY CHAIR

Central Study Contacts

FRANCESCA INCARDONA, DR

CONTACT

+393356112830; francesca.incardona@euresist.org

ANTONELLA D'ARMINIO MONFORTE, PROF

CONTACT

+390281843045; antonella.darminio@unimi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 8, 2022
• Study Start: July 1, 2022
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: AFTER THE STUDY END NO TIME LIMIT WAS FIXED
• Access Criteria: REQUEST TO THE STUDY COORDINATOR OR TO THE PROJECTPARTNERS

Locations

PT (1); LI (1); DE (1); IT (2); ME (1); GB (1)